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SFDA’s Guidance For Medical Device Maintenance Facilities

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SFDA has recently published a Guidance For Medical Device Maintenance Facilities; Click here to read the official document.

Published on: 12th January, 2021

Highlights from this Document

This guidance is to clarify the Saudi Food & Drug Authority (SFDA) requirements on the maintenance services of medical devices and supplies in health facilities to ensure the performance of the medical device according to its intended purposes by applying calibration,
planned preventative maintenance (PPM) and corrective maintenance (CM) during the usage of the medical device

This guidance applies to all medical devices maintenance faclilities in the kingdom of Saudi Arabia (KSA).

Page 4 to 8 in the guidance is the requirements for Medical Devices Maintenance Facilities.

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